Senior Medical Director, Clinical Development

Verastem•Boston, MA

11h

About The Position

Verastem Oncology is seeking a Medical Director or Senior Medical Director, with level dependent on qualifications, to provide medical and scientific leadership for late-phase solid tumor clinical development, focused on the VS-7375 KRAS G12D ON/OFF inhibitor program. The position leads the medical aspects of assigned Phase 3 pivotal trials, oversees medical monitoring, and contributes to regulatory filings and marketing authorization activities. It requires experience conducting late-phase oncology trials and preparing clinical content for regulatory submissions within a cross-functional, matrixed team. The role serves as the primary medical monitor and contact for assigned trials, providing medical oversight from trial design and execution through data review, analysis, reporting, and submission. It works with internal partners, CROs, investigators, external advisors, and health authorities to support trial conduct, assess safety and efficacy, inform development decisions, and prepare clinical and regulatory materials. The position also contributes to clinical presentations, scientific communications, and submission readiness.

Requirements

Medical degree (MD or equivalent).
At least 5 years of biotechnology or pharmaceutical industry experience in oncology clinical development, including direct responsibility for late-phase solid tumor trials.
Demonstrated experience designing, conducting, medically monitoring, and interpreting Phase 3 pivotal studies, including delivery through key analyses and clinical study reporting.
Hands-on contribution of clinical content to at least one oncology marketing application (NDA or equivalent), including submission preparation and filing, with direct involvement in health authority interactions and responses to agency questions.
Strong knowledge of Good Clinical Practice, the global drug development process, FDA and EMA requirements, and oncology efficacy and safety assessments, including RECIST, survival endpoints, and adverse event grading.
Sound medical judgment and ability to interpret complex data, assess benefit-risk, resolve clinical issues, and communicate clear recommendations to investigators and cross-functional teams.
Ability to work independently and collaboratively in a matrixed environment, manage competing priorities, and achieve clinical development milestones in a fast-paced biotechnology setting.
Excellent interpersonal, written communication, presentation, and influencing skills, with ability to build effective internal and external relationships.
Ability to travel up to 25% of the time.

Responsibilities

Lead the design and medical execution of assigned late-phase solid tumor trials in collaboration with Clinical Science, Clinical Operations, Biostatistics, Regulatory Affairs, and other study team members.
Partner with Clinical Operations on study plans, timelines, resource needs, and budget inputs; monitor milestones, identify risks, and resolve clinical issues affecting enrollment, trial conduct, data quality, and completion.
Serve as the primary medical monitor and medical contact for assigned trials; respond to investigator inquiries, assess eligibility questions, interpret protocols, and guide participant clinical management in accordance with protocols.
Oversee internal and external medical monitoring activities, including CRO support.
Review emerging safety and efficacy data, clinically significant laboratory findings, and protocol deviations, and escalate issues requiring action.
Collaborate with Pharmacovigilance on adverse event and serious adverse event review, safety signals, benefit-risk assessment, and risk mitigation measures.
Support independent data monitoring committee reviews and follow-up actions.
Partner with Clinical Science, Data Management, Biostatistics, and Statistical Programming on ongoing data reviews, medical queries, and preparation of clean, complete datasets for interim analyses, database lock, and final reporting.
Interpret and integrate efficacy, safety, pharmacology, and translational data to inform development decisions, indication expansion, and clinical evidence for regulatory filings.
Author and review protocols, amendments, investigator brochures, informed consent forms, clinical study reports, and clinical sections of regulatory submissions.
Work cross-functionally to ensure consistency of the clinical narrative and supporting evidence.
Contribute directly to NDA and, as applicable, MAA preparation and filing.
Develop and review clinical summaries and benefit-risk assessments, support integrated efficacy and safety analyses, and help respond to health authority questions.
Partner with Regulatory Affairs to prepare briefing documents and clinical presentations for health authority meetings; participate in agency interactions and support submission review and inspection readiness.
Build relationships with investigators, key opinion leaders, external medical advisors, and internal stakeholders.
Lead clinical presentations at investigator meetings and advisory boards, communicate program updates to leadership, and contribute to abstracts, manuscripts, and scientific presentations.
Travel up to 25% of the time.